| Date Initiated by Firm | March 24, 2014 |
|---|
| Date Posted | April 24, 2014 |
|---|
| Recall Status1 |
Terminated 3 on September 21, 2015 |
| Recall Number | Z-1494-2014 |
|---|
| Recall Event ID |
67831 |
| 510(K)Number | K121941 |
|---|
| Product Classification |
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
|
| Product | Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter. |
|---|
| Code Information |
lot #23F14A0375 |
Recalling Firm/
Manufacturer |
Arrow International Inc
2400 Bernville Road
Reading PA 19605
|
| For Additional Information Contact | Customer Support
610-378-0131 |
|---|
Manufacturer Reason
for Recall | Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter. |
|---|
FDA Determined
Cause 2 | Labeling mix-ups |
|---|
| Action | A recall notification letter, dated March 24, 2014 was sent to end users.
" Urgent Medical Device Recall Notification " |
|---|
| Quantity in Commerce | 789 |
|---|
| Distribution | Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LJS
|
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